title: Quality of life after severe trauma: results from the global trauma trial with recombinant Factor VII.
abstract: BACKGROUND
  Physical disability and psychologic morbidity are frequent and important complications of severe trauma injury with serious consequences for long-term health-related quality of life (HRQOL). Little prospective data exist, however, in a global trauma population on the risk factors for poor HRQOL.
  
  
  METHODS
  The CONTROL trial was a prospective, randomized, double-blinded, multicenter, placebo-controlled trial conducted from August 2005 to September 2008. HRQOL was assessed 3 months after injury using the Polytrauma Outcome Chart (Glasgow Outcomes Scale, Short Form 36, European Quality of Life-5 Dimensions (EQ-5D), and Trauma Outcome Profile). Multivariate stepwise regression analysis identified predictors of poor HRQOL.
  
  
  RESULTS
  Three hundred forty-seven (72%) patients completed at least one HRQOL instrument. Three percent had an EQ-5D score <0 (worse than death); 92% had a score <0.87 (average score in the general population). All HRQOL instruments identified physical functioning and activities of daily living as the dimensions of health most significantly affected by trauma injury. Mental functioning was also significantly affected according to the Trauma Outcome Profile. Independent predictors of poor HRQOL were higher age, female gender, extremity injury, blunt injury, intensive care unit stay >3 days, repeated nonadherence to transfusion guidelines, and inability to work postinjury.
  
  
  CONCLUSIONS
  Three months after severe trauma injury, survivors report very poor HRQOL. Physical wellbeing is generally more negatively affected than mental wellbeing. A trauma-specific HRQOL instrument reveals more diverse mental health problems than generic instruments. In a global trauma population, postinjury HRQOL is predicted by demographic and socioeconomic characteristics, type of injury, and treatment received.
authors.affiliation: Regulatory Affairs, Novo Nordisk A/S, Søborg, Denmark. mcrc@novonordisk.com
authors.forename: Michael C
authors.initials: MC
authors.lastname: Christensen
authors.forename: Claus
authors.initials: C
authors.lastname: Banner
authors.forename: Rolf
authors.initials: R
authors.lastname: Lefering
authors.forename: Laura
authors.initials: L
authors.lastname: Vallejo-Torres
authors.forename: Stephen
authors.initials: S
authors.lastname: Morris
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005167:Factor VII / Q000627:therapeutic use*; D005260:Female; D015600:Glasgow Coma Scale; D006470:Hemorrhage / Q000188:drug therapy* / Q000523:psychology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011446:Prospective Studies; D011788:Quality of Life; D012044:Regression Analysis; D012307:Risk Factors; D017741:Survivors / Q000523:psychology*; D015599:Trauma Severity Indices; D016896:Treatment Outcome; D014947:Wounds and Injuries / Q000188:drug therapy* / Q000523:psychology*
chemical_list: D010919:Placebos; D005167:Factor VII